Baxter Issues Recall for Volara Circuits and Adapter in Lung Therapy Component
This recall entails removing specific devices from locations where they are utilized or sold. The FDA has classified this recall as the most critical type. Continuing to use this device could result in severe injury or even fatality.
Product Involved
- Product Names: Volara System Single Patient Use Circuit and Blue Ventilator Adapter (sold separately from Volara System)
- Unique Device Identifier (UDI)/Product Codes:
- Single-patient use circuit: M08473, M08474
- Blue Ventilator Adapter Assembly: M07937
Recommended Actions
- Discontinue use of all affected patient circuits.
- If there are no alternatives for therapy, proceed with caution.
- Inspect the nebulizer port visually before therapy
- Monitor for any ventilator gas flow leaks throughout therapy
On May 30, 2024, Baxter issued an Urgent Medical Device Recall notice to affected customers outlining the following steps:
- Cease use of all affected lot numbers immediately.
- Return all impacted units.
- Inform others who may have received the affected products.
- Complete and return the acknowledgment form that was enclosed in the letter.
Replacement products (Blue Ventilator Adapter module) will be dispatched to users along with instructions for returning the affected products.
Reason Behind the Recall
Baxter is recalling certain Single Patient Use Circuits and Blue Ventilator Adapter Assemblies due to issues stemming from the handset plug possibly disconnecting from the nebulizer port on the blue ventilator adapter. Using the Volara system in line with a ventilator, without a nebulizer connected, makes the handset plug essential for proper function and gas flow. An unplugged connection may result in insufficient ventilation for the patient.
This product’s usage could lead to severe health issues, including a drop in oxygen levels (desaturation), which can cause injuries due to oxygen deprivation, including brain injury, heart attack, respiratory failure, and death.
Currently, there have been no reports of injuries or fatalities.
Device Application
The Volara System is designed for patients who require assistance in breathing via a ventilator. Its function includes airway expansion, treatment, and prevention of lung consolidation and atelectasis, as well as the movement and treatment of mucus and other airway secretions. It is positioned in the ventilator circuit tubes between the patient and the ventilator (in-line).
The Single Patient Use Circuit and Blue Adapter Assembly are integral patient circuit components that connect the Volara System to the ventilator and are sold separately from the primary system.
Contact Details
U.S. customers with inquiries regarding this recall should reach out to Baxter Advanced Respiratory customer service at 800-426-4224, selecting option 2 for Acute Care Customer Service or option 3 for Home Care Customer Service.
Further FDA Information
Additional Company Information
Unique Device Identifier (UDI)
The Unique Device Identifier (UDI) serves to differentiate individual medical devices that are sold in the U.S. from production to distribution and patient use. The UDI facilitates more precise reporting, analysis, and review of adverse event reports, allowing for swift identification of devices and potential resolution of issues.
How to Report an Issue
Healthcare professionals and consumers may report any adverse reactions or quality problems they encountered while using these devices to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.